BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3285813 · Received August 14, 2013

    Report

    Report Number
    1030489-2013-03513
    Event Type
    Injury
    Date Received
    August 14, 2013
    Date of Event
    July 14, 2012
    Report Date
    July 15, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. LITERATURE CITATION: STEVEN M. KURTZ, ET AL. RETRIEVAL ANALYSIS OF PEEK RODS FOR POSTERIOR FUSION AND MOTION PRESERVATION. EUROPEAN SPINE JOURNAL. 2013; ISSUE#: DOI 10.1007/S00586-013-2920-4.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SPINAL FUSION AT L5-S1 TO TREAT DISC DEGENERATION. IT WAS REPORTED THAT APPROXIMATELY 2.75 YEARS POST-OP THE PATIENT UNDERWENT A REVISION SURGERY DUE TO SCREW IMPINGEMENT OF THE L4¿5 FACET, NERVE ROOT ENCROACHMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389801 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Other